Mindfulness as a Mediator of Psychological Wellbeing in a Stress Reduction Intervention for Cancer Patients - a randomized study Richard Bränström Department of oncology-pathology Karolinska Institute Sweden
Background Getting a cancer diagnose is a intensely stressful experience Many patients experience negative physical symptoms, emotional distress and decreased quality of life Common complaints are: Anxiety Depression Post traumatic stress symptoms Sleep disturbance Fatigue Richard Bränström 23 juli 2009 2
The effects of mindfulness on health conditions Mindfulness based interventions has been used for a number of health conditions such as: Chronic pain Anxiety Depression Sleep disturbance Research provides support for effects of mindfulness interventions on quality of life and psychological functioning Richard Bränström 23 juli 2009 3
The effects of mindfulness interventions on cancer patients A couple of randomized trials Several non-randomised trials General conclusion: improved psychological functioning, reduction of stress symptoms, enhanced coping and wellbeing More research in the area is needed Richard Bränström 23 juli 2009 4
Mindfulness meditation The most frequently studied intervention is the Mindfulness-Based Stress Reduction (MBSR) program developed by Jon Kabat-Zinn at the University of Massachusetts Medical Centre It is a structured educational and skill-based intervention 8 weekly sessions and an additional intensive silent retreat Participants are encouraged to practice meditation daily during the program period Main components: self-regulation of awareness towards present mental states and processes non-evaluative openness and acceptance towards moment-tomoment experiences Richard Bränström 23 juli 2009 5
Mindfulness meditation, continued In all mindfulness exercises, participants are instructed to focus attention on breathing (or walking) and to be aware of it in each moment. When emotions, sensations, or cognitions arise, they are observed non-judgmentally An important consequence of mindfulness practice is to realise that most sensations, thoughts and emotions fluctuate and just pass by Richard Bränström 23 juli 2009 6
Study aim To study the effect of mindfulness meditation training on: Perceived stress Depression Anxiety Postive states of mind Post-traumatic stress symptoms To study the mediating effect of mindfulness skills on these outcomes Richard Bränström 23 juli 2009 7
Method Intervention A modified verision of the original MBSR program Eight weekly 2 hours group sessions (8 10 participants) Theoretical, experiential and group exercises The theoretical foundations of mindfulness are taught as a complement to exercises Meditation is trained in class and at home Training involves body scan meditation, sitting and walking meditation and hatha yoga Participants were encouraged to practice meditation 6 days a week at home using an instruction tape Richard Bränström 23 juli 2009 8
Method Study design A randomized design was used with a waiting-list control condition The study was open to patients with varying cancer diagnoses. Participant were recruited through advertisement and e-mail list announcement through cancer patient organizations Eligible patients were randomized to either intervention group or waiting-list control group The waiting-list participants was scheduled to participate in the mindfulness training program after approximately 6 months Assessments were done at baseline and at 3 and 6 month after baseline The current analysis is based on the results collected among the 60 patients recruited to the study that got randomized and also successfully filled out and returned the baseline and threemonth follow-up questionnaires Richard Bränström 23 juli 2009 9
Method Measures Perceived Stress Scale (PSS) The PSS is a ten item scale measuring perception of stressful experiences during the past month Hospital Anxiety and Depression Scale (HADS) a 15 item scale measuring anxiety and depression Positive States of Minds (PSOM) The PSOM is a six item scale measuring different positive emotional and cognitive experiences Impact of Event Scale (IES) a 15 item scale measuring the impact of stressful life events with three subscales: intrusive thinking, avoidance, and hyperarousal Five facet mindfulness questionnaire (FFMQ) a previously tested and validated scale to assess changes in ability to perform mindful attention Richard Bränström 23 juli 2009 10
Method Five facet mindfulness questionnaire (FFMQ; Baer, 2006) 39 item scale measuring five dimensions of mindfulness Developed after exploratory and confirmatory factor analysis of items form several different mindfulness scales A five factor model showed the most satisfying results: Observing Describing Act with awareness Non-judging of inner experiences Non-reactivity to inner experiences Richard Bränström 23 juli 2009 11
Results Descriptives All patients except one were women 46 had breast cancer, 7 gynecological cancer, 5 lymphatic cancer, 1 pancreatic cancer, and 1 had cancer in the neck Eight patients had received their diagnosis within the last year, 32 patients between 1 and 2 years ago, and 20 patients had been diagnosed with cancer more than 2 years ago Richard Bränström 23 juli 2009 12
Results Descriptive anaysis and randomization check The mean age was 52.2 years (SD=9.40) 36 of the participants (60.0%) had at least a bachelor degree 25 participants (41.7%) had full or part-time employment 23 participants (38.3%) used antidepressants There were no significant differences between the intervention and control group concerning age, education, work status, or use of antidepressants No differences were found on any of the psychological outcome variables perceived stress, depression, anxiety, positive states of mind, post traumatic stress symptoms, or mindfulness Richard Bränström 23 juli 2009 13
Results Change in psychological distress and positive states of mind A multivariate analysis with baseline and follow-up on psychological outcomes showed a significant time group interaction effect The intervention group reported a larger reduction of psychological distress and increase in positive states of mind than the control group Richard Bränström 23 juli 2009 14
Results Change scored for psychological outcome variables between baseline and 3 month follow-up Richard Bränström 23 juli 2009 15
Results Change in mindfulness A multivariate analysis with baseline and follow-up on mindfulness subscales showed a significant effect for the time group interaction The intervention group reported a larger increase on mindfulness subscales than the control group Richard Bränström 23 juli 2009 16
Results Change scores on the five subscales of mindfulness from baseline and 3 month follow-up Richard Bränström 23 juli 2009 17
Results Correlation between change in mindfulness and changes in psychological wellbeing Total mindfulness score observing describing non judging of inner experience nonreactivity to inner experience acting with awareness Perceived stress 0,54*** 0,20 0,41*** 0,36** 0,55*** 0,36** Depression 0,40*** 0,16 0,25 0,28* 0,41*** 0,32* Anxiety 0,36** 0,06 0,38** 0,23 0,32* 0,26* Positive states of mind 0,52*** 0,39** 0,41*** 0,33* 0,40** 0,28* Post traumatic stress symptoms: IES Intrusion 0,17 0,03 0,16 0,07 0,29* 0,07 IES Avoidance 0,49*** 0,14 0,37** 0,44*** 0,39** 0,33** IES Hyperarousal 0,30* 0,06 0,23 0,13 0,35** 0,33** * = p < 0.05, ** = p < 0.01, *** = p < 0.001 Richard Bränström 23 juli 2009 18
Results The effect of mindfulness as a mediator Change in mindfulness β = 0.53, p < 0.01 β = 0.45, p < 0.01 Group (intervention vs. control) β = 0.30, p < 0.05 β = 0.08, n.s. Perceived stress at follow up Richard Bränström 23 juli 2009 19
Results The effect of mindfulness as a mediator Change in mindfulness β = 0.53, p < 0.01 β = 0.36, p < 0.05 Group (intervention vs. control) β = 0.30, p < 0.01 β = 0.10, n.s. Positive states of mind at follow up Richard Bränström 23 juli 2009 20
Results The effect of mindfulness as a mediator Change in mindfulness β = 0.53, p < 0.01 β = 0.27, p < 0.05 Group (intervention vs. control) β = 0.29, p < 0.001 β = 0.14, n.s. IES avoidance at follow up Richard Bränström 23 juli 2009 21
Summary Mindfulness training seems to: Reduce perceived stress Increased postive states of mind Reduce post traumatic avoidance symptoms Reduce post traumatic hyperarousal symptoms Mindfulness training seemed to increase mindfulness and different dimensions of mindfulness as measures with the FFMQ Change in mindfulness mediated the relationship between intervention participation and: Perceived stress Postive states of mind Post traumatic avoidance symptoms Richard Bränström 23 juli 2009 22
Conclusions The present study indicates that the improvements in psychological wellbeing resulting from mindfulness stress reduction training can be explained by increased levels of mindfulness This supports the use of mindfulness stress reduction training to increase wellbeing among cancer patients, and suggests a causal pathway in which the mindfulness training influences positive outcomes The study also gives support for the use of the FFMQ in the measurement of mindfulness as it shows that the scale is both sensitive to change over time, and to the development of mindfulness, as promoted by a mindfulness-based stress reduction program Richard Bränström 23 juli 2009 23
Limitations and future directions Participants were self-selected which might have generated a group of highly motivated participants Our follow-up period was relatively brief The wait-list control design is limited as it is unclear what part of the intervention is actually influencing outcomes and a study design using an active placebo intervention would give stronger support for the specific effects of the mindfulness intervention The study also suffers from the limitations associated with selfreport Future research could focus on understanding which specific elements of the mindfulness training influence particular sub dimensions of mindfulness and psychological outcomes Studies among patients with specific cancer diagnoses at particular times after diagnosis might clarify when and for whom mindfulness interventions are the most efficient. Richard Bränström 23 juli 2009 24
Acknowledgements Pia Kvillemo & Yvonne Brandberg Department of oncology-pathology Karolinska Institute Judith T. Moskowitz Osher Center for Integrative Medicine University of Californa San Francisco Funding: Osher center for integrative medicine at the Karolinska Institute Centrerfor Health Care Sciences at the Karolinska Institute Richard Bränström 23 juli 2009 25
Results Means and standard deviations of psychological outcome variables at baseline and 3 month follow-up Mindfulness intervention Wait list control Change scores Pre Post Pre Post Intervention Control Intervention effect Effect size Mean SD Mean SD Mean SD Mean SD Mean SD Mean SD F(1,55) p d a diff Perceived stress 22.88 6.15 15.64 6.42 20.40 5.35 18.33 6.12 7,24 6,80 2,07 5,99 10.47 0.002 0.80 Depression 6.84 4.64 4.61 4.45 7.09 3.56 6.31 3.24 2,23 3,25 0,77 2,93 3.09 0.084 0.47 Anxiety 10.60 4.64 7.69 4.15 10.14 4.52 8.86 3.68 2,91 4,11 1,28 3,24 3.51 0.066 0.44 Positive states of mind 18.72 3.71 22.64 4.35 18.74 3.85 20.00 4.26 3,92 3,84 1,26 3,48 9.22 0.004 0.73 Post traumatic stress symptoms: IES Intrusion 12.72 5.88 10.15 4.35 15.17 6.55 13.43 6.78 2,57 4,31 1,74 5,34 0.38 0.54 0.17 IES Avoidance 10.17 6.59 6.18 6.30 12.09 7.62 11.86 7.41 3,99 4,73 0,23 5,26 8.43 0.005 0.75 IES Hyperarousal 9.56 5.43 5.44 4.73 10.77 5.76 9.11 5.58 4,12 3,69 1,66 4,45 4.42 0.040 0.60 a The effect size was calculated based on the difference between the groups regarding baseline and follow up change scores. Richard Bränström 23 juli 2009 26
Results Means and standard deviations of the five subscales of mindfulness at baseline and 3 month follow-up Mindfulness intervention Wait list control Change scores Pre Post Pre Post Intervention Control Intervention effect Effect size Mindfulness subscales: Mean SD Mean SD Mean SD Mean SD Mean SD Mean SD F(1,55) p d diff a Observing 28.96 5.98 32.66 4.12 27.54 6.01 27.31 5.62 3,70 5,26 0,23 4,49 9.41 0.003 0.80 Describing 27.66 7.77 29.60 8.05 28.27 7.92 26.83 8.50 1,94 4,80 1,44 4,16 8.35 0.005 0.75 Act with awareness 24.03 6.78 28.72 6.02 20.31 6.52 21.97 6.39 4,69 4,76 1,66 4,54 6.44 0.014 0.65 Non judgment of inner experiences Non reactivity to inner experiences 24.96 8.18 31.36 6.58 23.46 7.75 25.71 7.78 6,40 6,87 2,26 5,20 8.24 0.006 0.68 16.73 4.83 22.20 4.34 17.60 4.86 19.48 5.19 5,47 3,21 1,88 3,54 16.18 0.001 1.06 a The effect size was calculated based on the difference between the groups regarding baseline and follow up change scores. Richard Bränström 23 juli 2009 27
Evidence for effects of mindfulness on other health conditions, continued A meta-analysis published in 2003 by Baer showed an average effect size of 0.59 for mindfulness interventions Mean effect sizes were similar for studies using pre-post and between-groups designs Mean effect size was somewhat larger when participants had been randomly assigned Studies using waiting-list control groups yielded slightly larger effect sizes than those using control groups treated as usual Mean effect sizes ranged from 0.31 for pain measures to 0.86 for measures of depression Richard Bränström 23 juli 2009 28
The effect of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients Speca, M, Carlson, LE & Goodey, E et al. (2000) 90 patients, heterogeneous in type and stage of cancer Randomly assigned to either intervention or wait-list control group Intervention consisted of 7 weekly 90-minutes group sessions Outcome measures: Profile of mood states and Symptoms of stress inventory Results: Significant disease in distress and stress symptoms Minutes of practice and number of sessions attended increased the effect Effects were maintained after 6 months (Carlson et al. 2001) Richard Bränström 23 juli 2009 29
The efficacy of mindfulness-based stress reduction in the treatment of sleep disturbance in women with breast cancer Shapiro, SL et al. (2003) 54 patients, women with stage II breast cancer Part of a larger randomised study Intervention consisted of 6 weekly 120 minute sessions + retreat Outcome measures: Sleep quality measures Results: Significant increase in sleep quality Richard Bränström 23 juli 2009 30
Change in women s diet and body mass following intensive intervention for early-stage breast cancer Hebert, JR et al. (2001) 172 patients, women with stage I or II breast cancer Intervention consisted of either nutrition education, mindfulness training or usual supportive care Outcome measures: Dietary fat consumption and body mass Results: No decrease in dietary fat or body mass in mindfulness training group Richard Bränström 23 juli 2009 31
85 patients were initially recruited Results Flow chart describing study recruitment and drop-out Randomization: 39 to intervention and 46 to control group Baseline assessment: 71 patients 14 participants dropped-out (7 intervention / 7 control) Intervention group: 32 patients Wait-list control group: 39 patients 7 did not return followup questionnaire 4 did not return followup questionnaire 60 participants completed the 3-month follow-up assessment and were included in the final analysis Richard Bränström 23 juli 2009 32
Mindfulness meditation How can mindfulness skills help? Exposure Prolonged focus on and non-judgmental observations of a phenomena (e.g. pain, anxiety) may lead to desensitisation, with a reduction over time of the emotional responses or reactivity. Fear and avoidant behaviour might diminish with prolonged nonjudgmental observation of current thought and emotions Cognitive change the non-judgmental, decentred view of one s thoughts encouraged by mindfulness training may interfere with negative patterns of thoughts characteristic of depressive episodes Self-management Improved self-observation, resulting from mindfulness training, may promote use of a range of coping skills e.g. awareness of early signs of a problem like depression or urge to binge eat Richard Bränström 23 juli 2009 33
Mindfulness meditation How can mindfulness skills help? Relaxation Relaxation is not a primary target for mindfulness meditation by may be a result of mindfulness exercises. Relaxation might have a beneficial effect on stress-related conditions Acceptance Mindfulness meditation include acceptance of pain, thoughts, feelings, urges, or other bodily, cognitive, and emotional phenomena, without trying to change, escape, or avoid them Richard Bränström 23 juli 2009 34